CE Marked medical device with CE mark 0483, indicating conformity assessment by a notified body.
Class IIa sterile lubricating jelly medical device (as per general classification for OptiLube sterile lubricating jelly range).
Supplied sterile and sterilised using moist heat after packaging, with single sterile barrier system plus protective packaging.
Validated by Hologic for use with the ThinPrep Pap Test when used as instructed.
Manufactured under quality management systems applicable to medical devices by Sion Biotext Medical Ltd and distributed by Optimum Medical Solutions Ltd.
CE Marked medical device with CE mark 0483, indicating conformity assessment by a notified body.
Class IIa sterile lubricating jelly medical device (as per general classification for OptiLube sterile lubricating jelly range).
Supplied sterile and sterilised using moist heat after packaging, with single sterile barrier system plus protective packaging.
Validated by Hologic for use with the ThinPrep Pap Test when used as instructed.
Manufactured under quality management systems applicable to medical devices by Sion Biotext Medical Ltd and distributed by Optimum Medical Solutions Ltd.
OptiLube Zero 5g Sachets (product code 1170) are sterile, clear, water-soluble lubricating jelly sachets that contain zero carbomers, zero parabens and zero chlorhexidine. Supplied as a box of 150 single-use 5g sachets, OptiLube Zero is designed to provide optimal lubrication to aid the smooth insertion of medical devices during a wide range of diagnostic and therapeutic procedures, while supporting best-practice infection prevention through individual patient-use packaging.
Bnefits
Carbomer-free, paraben-free and chlorhexidine-free formulation, reducing exposure to these excipients while maintaining effective lubrication.
Sterile, clear, colourless, non-sticky, non-greasy and non-staining gel that is non-irritating to the skin, improving patient comfort.
Water-soluble, high-viscosity gel that spreads easily, adheres well to instruments and is easily rinsed off with water after procedures.
Single-use 5g sachets designed for individual patient use promote increased infection control and reduce risk of patient-to-patient cross-contamination.
Individually packed sachets help reduce product waste compared to multi-use tubes, as only the required amount is opened for each patient.
Use of sterile lubrication during diagnostic and therapeutic procedures has been shown to increase patient comfort, reduce the risk of trauma and reduce the risk of infection.
Validated by Hologic for use with the ThinPrep Pap Test when used as instructed, supporting safe use in cervical screening and gynaecological procedures.
Supplied sterile and sterilised by moist heat after packaging, with clear IFU and labelling for professional hospital and clinical use.
Compatible with a wide range of medical devices, including catheters, endoscopes, surgical instruments and gynaecological and rectal devices.
Distributed globally by Optimum Medical Solutions with support materials and IFU available, ensuring traceability and regulatory compliance.
Indications
Intended to lubricate body orifices to assist insertion of medical devices for diagnostic and therapeutic purposes.
Typical uses include insertion of urinary catheters, endoscopes, surgical instruments and specula.
Suitable for gynaecological, rectal and oral procedures and examinations where a sterile water-soluble lubricant is required.
Intended users include patients, their carers and healthcare professionals, in hospital and professional clinical settings.
Validated for use with the ThinPrep Pap Test when used as instructed.
Composition
Processed (purified) water.
Hydroxyethyl cellulose QP-100 MH (gelling agent).
Sodium hydroxide 20% (pH adjustment).
Sodium benzoate (preservative).
Sodium EDTA (chelating agent).
Propylene glycol (humectant).
Glycerine (humectant).
Polysorbate 20 (surfactant/emulsifier).
Lactic acid.
Formulated with zero carbomers, zero parabens and zero chlorhexidine.
Non-sticky, non-greasy, non-staining and non-irritating lubricant to the skin.
Water-based formulation designed for use as a lubricating medium for insertion of medical instruments during medical procedures.
Easily rinsed off with water after use.
Supplied as a 5g single-use sachet for individual patient use.
Packaging
Box containing 150 single-use 5g sachets of OptiLube Zero lubricating jelly.
Each sachet is an individual sterile barrier system, to be opened immediately before use.
Product code: 1170; described as OptiLube Zero 5g sachet.
Supplied sterile and sterilised by moist heat after packaging.
Outer carton carries product identification, batch number, expiry date, CE mark and relevant symbols; sachets are easy to tear for quick application.
Usage
OptiLube Zero sachets are sterile and single-use; verify that the sachet and outer packaging are intact and within the expiry date before use.
Do not use the sachet if it is torn, damaged or cut, or if there is any doubt about sterility.
Tear the sachet open at one end along the indicated tear line.
Squeeze the sachet to obtain the desired amount of lubricating jelly.
Apply the gel directly to the medical device and/or to the relevant body orifice, as required for the procedure.
Proceed with insertion of the medical device in line with local clinical protocols and the device manufacturer’s instructions.
Avoid contact with eyes and ears; if accidental contact occurs, rinse thoroughly with water and seek medical advice if irritation persists.
Discard any unused gel remaining in the sachet after the procedure; do not reuse or attempt to resterilise the sachet.
After the procedure, excess gel may be gently wiped away and, if needed, rinsed off with water.
Dispose of used sachets and any associated consumables according to local clinical waste policies and procedures.
Contraindications
Do not use if the sachet is torn, damaged or cut, or if sterility is compromised.
Do not use in patients with known hypersensitivity or allergy to any of the ingredients (e.g. sodium benzoate, propylene glycol, glycerine, polysorbate 20 or other excipients).
Avoid contact with eyes and ears; if this occurs accidentally, rinse thoroughly with water and seek medical advice if irritation persists.
Re-use of this single-use medical device is contraindicated, as it may result in infection and/or cross-contamination.
Resterilisation, reprocessing, cleaning or disinfection of the sachet or contents is contraindicated, as it may compromise product characteristics and result in trauma or infection.
Adverse Effects
There are no known common side effects when used as directed.
In rare cases, local irritation or hypersensitivity reactions may occur, with symptoms such as redness, itchiness or blistering at the site of application.
If signs of irritation or hypersensitivity occur, discontinue use immediately and consult a healthcare professional.
Any serious incident related to the device should be reported to the manufacturer and to the competent authority in the user’s country.
Storage Conditions
Store at room temperature as indicated in the IFU.
Keep dry and out of direct sunlight.
Avoid excessive heat and humidity during storage and transport.
Do not use after the labelled expiry date.
Keep out of reach of children.
Do not use if the package is damaged; consult the instructions for use if there are any concerns about storage or handling conditions.
Duration
Not applicable; OptiLube Zero is used as a single-use lubricating aid during individual diagnostic or therapeutic procedures rather than over a defined treatment course.
Onset
Immediate lubricating effect upon application to the medical device and/or body orifice.
